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| December 2010 | Realising European
potential in synthetic biology
EASAC
6.4 Intellectual property rights
Patenting is also often viewed as an ethical issue.
The patentability of biotechnology inventions is
well established under the European Commission’s
Biotechnology Directive 98/44/EC and its implementation
in the European Patent Convention, using standard
criteria for inventiveness. Exceptions are made for
inventions contrary to morality. GMOs, microbiological
processes and products thereof are patentable as a matter
of principle. However, the morality clauses in European
Patent Law are diffi cult to interpret and the EGE has
probably not yet been suffi ciently involved in discussion of
ethical implications relating to patenting.
The Royal Society report on synthetic biology notes that
there are unresolved intellectual property rights (IPR)
issues in synthetic biology with some tension already
appearing between scientists and their universities
regarding the potential commercialisation of innovative
research (for example, in biofuels). Furthermore, the
magnitude of the resources needed in synthetic biology
makes private sector participation in basic research
essential and the private sector can be induced to invest
only if to some degree it can appropriate the results of its
research.
The publication by the Royal Academy of the Netherlands
and the German Statement on synthetic biology identify
two main problems in IPR protection in synthetic biology:
(1) overly broad patents may create monopolies,
hamper collaboration and stifl e innovation by other
researchers;
(2) narrow patents may impede subsequent applications
(for example, to set up a production system using
standard components) because of the complexity of
licensing arrangements to deal with multiple patent
holders (patent thickets).
These challenges were discussed in detail at the
Berlin meeting and patenting problems may seem
to be accentuated in synthetic biology because of its
multidisciplinarity (requiring patent expertise drawn from
several disciplines), compounded by the complexity of
products bringing together many defi ned parts and their
necessary interconnectedness to achieve functionality.
However, an alternative case can be made (Calvert
the USA
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. The initiative by the Industry Association
for Synthetic Biology to develop a global code of
conduct
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for DNA sequence screening, customer
screening and ethical, safe and secure conduct in
gene synthesis is a welcome step. Co-ordinated
screening of potential orders requires companies to
share access to international databases of sequence
information (with their functional correlates).
Companies producing synthetic sequences also
need a national contact point to consult if they
encounter suspect orders. As noted by the EGE
(Appendix 2), further discussion is needed to define
the responsibilities of the European Commission
and national Competent Authorities in assuring the
database(s) and acting on suspicious requests so as
to provide a comprehensive security framework.
However, given the potential range of synthetic
biology technologies, should control focus only on
genetics and genomics? A case could be made that
control is less necessary in a research area such as
protocells, because the technical difficulty involved
in such experiments means that they are likely to
be confined to specialist research establishments.
Moreover, the more different a synthetic biology
system is from the natural system, the safer it is likely
to be, because of the lack of interaction/integration
with natural organisms. Paradoxically, however, it
is the most unnatural systems that may be liable to
provoke the most public concern.
The academies and the scientifi c community more
generally must be involved in the continuing debate
to fi nd the right balance between self-governance
and statutory regulation. In the survey conducted
by Synbiosafe (Appendix 2, Ganguli-Mitra et al.
2009), synthetic biology researchers recognised it
was important to prevent the public backlash that
undermined agricultural GMO development. Most
researchers in this survey would opt for a mix of
international guidelines, national laws and self-
regulation, accompanied by initiatives in education
and raising awareness. The scientifi c community
must show leadership in open public debate but few
synthetic biology researchers judged the ‘civil society
participatory approach’ as particularly robust or
feasible or likely to provide the requisite fl exibility to
avoid the danger of constraining unforeseen advances
in science and technology.
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A US report prepared by the Craig Venter Institute together with the Center for Strategic and International Studies and MIT
(‘Synthetic Genomics: options for Governance’, 2007 at www.jcvi.org/research/synthetic-genomics-report) identifi ed three
main areas for policy intervention:
(1) Options for fi rms that supply synthetic DNA (including oligonucleotides)—e.g. fi rms must use special software to screen
orders for potentially harmful DNA.
(2) Options to regulate DNA synthesisers and reagents—e.g. owners of DNA synthesisers might be required to register their
machines or be licensed to purchase reagents.
(3) Options for legitimate users of synthetic genome technologies—e.g. education modules, previous review of experiments.
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‘Code of conduct for best practices in gene synthesis’ at www.ia-sb.eu.